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42 U.S.C. § 300cc–17Information services

submitted 82 years ago by Pub. L. 100-607 to r/title-42-THE-PUBLIC-HEALTH-AND-WELFARE · 621 words · no verdicts yet

in plain englishAI-generated · not legal advice

The Secretary must run a coordinated information program on AIDS research, treatment, and prevention. This includes a toll-free phone line for health workers and two data banks — one on AIDS research results, one on clinical trials and treatments. The data gets shared with patients, providers, and researchers.

(a) Establishment of program: The Secretary must set up, maintain, and run a program that shares information about research, treatment, and prevention activities related to HIV infection. This program must be integrated and coordinated across the agencies of the Department of Health and Human Services. (b) Toll-free telephone communications for health care entities: (1) After consulting the Director of the Office of AIDS Research, the Administrator of the Health Resources and Services Administration, and the Director of the CDC, the Secretary must set up toll-free phone service that gives medical and technical AIDS information to health care professionals, allied health care providers, and people providing emergency health services. (2) That information must include (A) information on preventing exposure to and transmission of the AIDS virus, and (B) information from the two data banks described in (c) and (d). (c) Data bank on research information: (1) After consulting the Director of the Office of AIDS Research, the Director of the CDC, and the National Library of Medicine, the Secretary must build a data bank holding the results of AIDS research done in the United States and other countries. (2) The Secretary must collect, catalog, store, and share this information, and, as much as practical, make it available to researchers, doctors, and other appropriate people in other countries too. (d) Data bank on clinical trials and treatments: (1) After consulting the Commissioner of Food and Drugs, the AIDS Research Advisory Committee set up under section 300cc–3, and the Director of the Office of AIDS Research, the Secretary must build a second data bank — called the "Data Bank" — holding information on clinical trials and treatments for HIV infection. (2) The Secretary must collect, catalog, store, and share this information, spreading it through information systems that reach people infected with HIV, the general public, health care providers, and researchers. (e) Requirements with respect to data bank on clinical trials and treatments: The Data Bank must contain two kinds of information. (1) A registry of clinical trials of experimental AIDS treatments run under FDA rules (section 355 of title 21). Each listing describes the purpose of the experimental drug protocol — either with the trial sponsor's consent, or once an efficacy trial begins — and must include who can join the trial and where the trial sites are. The trial's sponsor must send this information to the Data Bank within 21 days after the FDA approves the trial. (2) Information about experimental AIDS treatments that may be available through a "treatment investigational new drug" application submitted to the FDA under federal regulations (part 312 of title 21, Code of Federal Regulations). With the sponsor's consent, the Data Bank must also include the results of clinical trials of these treatments, including information about possible toxic effects or side effects.
the actual law source: uscode.house.gov ↗public domain
(a) Establishment of program

The Secretary shall establish, maintain, and operate a program with respect to information on research, treatment, and prevention activities relating to infection with the etiologic agent for acquired immune deficiency syndrome. The program shall, with respect to the agencies of the Department of Health and Human Services, be integrated and coordinated.

(b) Toll-free telephone communications for health care entities
(1)

After consultation with the Director of the Office of AIDS Research, the Administrator of the Health Resources and Services Administration, and the Director of the Centers for Disease Control and Prevention, the Secretary shall provide for toll-free telephone communications to provide medical and technical information with respect to acquired immune deficiency syndrome to health care professionals, allied health care providers, and to professionals providing emergency health services.

(2)

Information provided pursuant to paragraph (1) shall include—

(A)

information on prevention of exposure to, and the transmission of, the etiologic agent for acquired immune deficiency syndrome; and

(B)

information contained in the data banks established in subsections (c) and (d).

(c) Data bank on research information
(1)

After consultation with the Director of the Office of AIDS Research, the Director of the Centers for Disease Control and Prevention, and the National Library of Medicine, the Secretary shall establish a data bank of information on the results of research with respect to acquired immune deficiency syndrome conducted in the United States and other countries.

(2)

In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. To the extent practicable, the Secretary shall make such information available to researchers, physicians, and other appropriate individuals, of countries other than the United States.

(d) Data bank on clinical trials and treatments
(1)

After consultation with the Commissioner of Food and Drugs, the AIDS Research Advisory Committee established under section 300cc–3 of this title, and the Director of the Office of AIDS Research, the Secretary shall, in carrying out subsection (a), establish a data bank of information on clinical trials and treatments with respect to infection with the etiologic agent for acquired immune deficiency syndrome (hereafter in this section referred to as the “Data Bank”).

(2)

In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems available to individuals infected with the etiologic agent for acquired immune deficiency syndrome, to other members of the public, to health care providers, and to researchers.

(e) Requirements with respect to data bank on clinical trials and treatments

The Data Bank shall include the following:

(1)

A registry of clinical trials of experimental treatments for acquired immune deficiency syndrome and related illnesses conducted under regulations promulgated pursuant to section 355 of title 21 that provides a description of the purpose of each experimental drug protocol either with the consent of the protocol sponsor, or when a trial to test efficacy begins. Information provided shall include eligibility criteria and the location of trial sites, and must be forwarded to the Data Bank by the sponsor of the trial not later than 21 days after the approval by the Food and Drug Administration.

(2)

Information pertaining to experimental treatments for acquired immune deficiency syndrome that may be available under a treatment investigational new drug application that has been submitted to the Food and Drug Administration pursuant to part 312 of title 21, Code of Federal Regulations. The Data Bank shall also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, of such experimental treatments, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatment.

Source credit: (July 1, 1944, ch. 373, title XXIII, § 2317, as added Pub. L. 100–607, title II, § 201(4), Nov. 4, 1988, 102 Stat. 3071; amended Pub. L. 100–690, title II, § 2617(c), Nov. 18, 1988, 102 Stat. 4240; Pub. L. 102–531, title III, § 312(d)(19), Oct. 27, 1992, 106 Stat. 3505; Pub. L. 103–43, title XX, § 2008(d)(4), June 10, 1993, 107 Stat. 212.)

history & why it existsrecord from the source credit
  • 1944Enacted · Pub. L. 100-607 · 102 Stat. 3071
  • 1988Amended · Pub. L. 100-690 · 102 Stat. 4240
  • 1992Amended · Pub. L. 102-531 · 106 Stat. 3505
  • 1993Amended · Pub. L. 103-43 · 107 Stat. 212

A history note hasn’t been published yet. The record shows enactment by Pub. L. 100-607 on 1944-07-01.

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